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Area of Science:

  • Endocrinology
  • Andrology
  • Clinical Chemistry

Background:

  • Direct measurement of serum free testosterone (mFT) is crucial for evaluating male hypogonadism.
  • Limited availability of reference ranges for mFT hinders clinical application.

Purpose of the Study:

  • To establish age-stratified reference ranges for measured free testosterone (mFT) in healthy, community-dwelling adult men.
  • To provide data for improved clinical evaluation of hypogonadism.

Main Methods:

  • Serum samples from 1202 Caucasian men were analyzed.
  • Measured free testosterone (mFT) determined by equilibrium dialysis and LC-MS/MS.
  • Reference ranges established using Clinical & Laboratory Standards Institute guidelines, defining the 2.5th and 97.5th percentiles.

Main Results:

  • The reference range for mFT in healthy, non-obese men (18-39 years) was 184-749 pmol/L.
  • mFT levels declined with age (-4.5 pmol/L per year).
  • Increased BMI (30 and 35 kg/m²) significantly decreased mFT compared to a reference BMI of 22 kg/m².

Conclusions:

  • Age-stratified reference ranges for mFT were established in the largest cohort to date.
  • mFT levels are significantly influenced by age and BMI.
  • Further research is needed on optimal implementation of mFT and calculated FT in clinical practice.